P2-03 Swog S1011–subgroup Analysis of the Phase Iii Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer

You have accessJournal of UrologyParadigm-shifting, Practice-changing Clinical Trials in Urology (P2)1 May 2024P2-03 SWOG S1011–SUBGROUP ANALYSIS OF THE PHASE III SURGICAL TRIAL TO EVALUATE THE BENEFIT OF A STANDARD VERSUS AN EXTENDED LYMPHADENECTOMY PERFORMED AT TIME OF RADICAL CYSTECTOMY FOR MUSCLE INVASIVE UROTHELIAL CANCER Seth P. Lerner, Catherine Tangen, Robert S. Svatek, Siamak Daneshmand, Kamal Pohar, Eila Skinner, Anne Schuckman, Arthur I. Sagalowsky, Norm D. Smith, Ashish M. Kamat, Wassim Kassouf, Melissa Plets, Rick Bangs, Theresa M. Koppie, Ajai Alva, Francisco G. La Rosa, Sumanta K. Pal, Adam S. Kibel, Daniel J. Canter, and Ian M. Thompson Seth P. LernerSeth P. Lerner , Catherine TangenCatherine Tangen , Robert S. SvatekRobert S. Svatek , Siamak DaneshmandSiamak Daneshmand , Kamal PoharKamal Pohar , Eila SkinnerEila Skinner , Anne SchuckmanAnne Schuckman , Arthur I. SagalowskyArthur I. Sagalowsky , Norm D. SmithNorm D. Smith , Ashish M. KamatAshish M. Kamat , Wassim KassoufWassim Kassouf , Melissa PletsMelissa Plets , Rick BangsRick Bangs , Theresa M. KoppieTheresa M. Koppie , Ajai AlvaAjai Alva , Francisco G. La RosaFrancisco G. La Rosa , Sumanta K. PalSumanta K. Pal , Adam S. KibelAdam S. Kibel , Daniel J. CanterDaniel J. Canter , and Ian M. ThompsonIan M. Thompson View All Author Informationhttps://doi.org/10.1097/01.JU.0001015816.87470.c9.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract BACKGROUND: S1011 demonstrated that patients with MIBC undergoing RC and ELND had increased node yield and higher pathologic N stage, but no significant DFS or OS benefit compared to patients undergoing SLND (NCT01224665). In the present analysis we report analysis of secondary endpoints that may impact adverse events (AEs), DFS and OS. METHODS: Eligible patients with cT2-4a N0-2 were stratified by receipt and type of neoadjuvant chemotherapy (NAC), T2 vs T3-4a and PS 0-1 vs 2. All patients underwent a standard bilateral pelvic LND including external and internal iliac and obturator LNs. If randomized to the experimental arm additional ELND up to at least the aortic bifurcation including common iliac (CI), pre-sciatic, and pre-sacral nodes was performed. We evaluated pre-specified and additional secondary objectives of operative time, length of stay (LOS), blood tx, diversion type, peri-operative chemotherapy association with G3-5 AEs, DFS and OS and impact of LN mets/LN density and patterns of recurrence stratified by local, distant, and local and distant progression. RESULTS: 658 patients were registered from 8/11-2/17, and 592 eligible patients were randomized to ELND (n=292) or SLND (n=300). Median f/up was 6.1 years in both arms. ELND had more patients with at least one grade 3-5 AE within 90 days of surgery: 55% vs. 43% for SLND, including patients who progressed and died (p=0.004). There was a higher rate of VTEs in the ELND arm. Although operative time (OT) was longer in the ELND group, OT was not associated with high grade AEs. Ileal conduit was associated with worse OS, but diversion type was not associated with high grade AEs. Variant histology (present in 13%) and blood transfusions were not associated with DFS or OS, though intraoperative estimated blood loss (EBL) was higher in ELND group. Among patients who recurred, the first site of recurrence for SLND patients was local in 23%, distant in 62%, or both local and distant in 12%. For ELND patients first site of recurrence was 35%, 51% and 11%, respectively. The overall local recurrence (LR) rate was 12.7% in ELND and 9% in SLND. CONCLUSIONS: Patients with MIBC undergoing RC and ELND had increased node yield and higher pathologic N stage, but no significant DFS or OS benefit compared to patients undergoing SLND. VTEs were more common in ELND but there was no association of EBL, OT, or diversion type with high grade AEs. Among the secondary endpoints, only Ileal conduit was associated with worse OS. Source of Funding: NIH/NCI grant awards U10CA180888 U10CA180819, U10CA180820, U10CA180821, and U10CA180863 and Canadian Cancer Society grant# 707213 © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5S2May 2024Page: e2 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Seth P. Lerner More articles by this author Catherine Tangen More articles by this author Robert S. Svatek More articles by this author Siamak Daneshmand More articles by this author Kamal Pohar More articles by this author Eila Skinner More articles by this author Anne Schuckman More articles by this author Arthur I. Sagalowsky More articles by this author Norm D. Smith More articles by this author Ashish M. Kamat More articles by this author Wassim Kassouf More articles by this author Melissa Plets More articles by this author Rick Bangs More articles by this author Theresa M. Koppie More articles by this author Ajai Alva More articles by this author Francisco G. La Rosa More articles by this author Sumanta K. Pal More articles by this author Adam S. Kibel More articles by this author Daniel J. Canter More articles by this author Ian M. Thompson More articles by this author Expand All Advertisement PDF downloadLoading ...